Back to resultsRandomized Safety Study of CVT-301 Compared to an Observational Control Group
Primary Purpose
Idiopathic Parkinson's Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CVT-301
Observational cohort
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Parkinson's Disease focused on measuring Parkinson's Disease, Motor fluctuations, levodopa, inhaled drugs, OFF episodes
Eligibility Criteria
Inclusion Criteria:
- Has signed and dated an Internal Review Board/Independent Ethics Committee (IRB/IEC)-approved informed consent form before any protocol-specific screening procedures are performed.
- Women of child-bearing potential must use protocol-defined contraceptive measures and must have a negative serum human chorionic gonadotropin (hCG) test at screening. These patients must be willing to remain on their current form of contraception for the duration of the study.
- Patients who have idiopathic PD (i.e., not induced by drugs or other diseases) as defined by fulfilling Steps 1 and 2 of the United Kingdom (UK) Brain Bank criteria, diagnosed after the age of 30 years.
- Patients who are classified as Stage 1 to 3 (in the ON state) on the modified Hoehn and Yahr scale for staging of PD severity.
- Patients who have experienced motor fluctuations for a minimum of 2 hours of average daily OFF time per waking day (excluding early morning OFF time) by self-report and confirmed by the PD Diary (on 3 consecutive days) during the screening period.
Exclusion Criteria:
- Patients who have dyskinesia of a severity that would significantly interfere with their ability to participate or perform study procedures.
- Pregnant or lactating females or females wishing to become pregnant.
- Patients who have any known contraindication to the use of levodopa (LD), including a history of malignant melanoma or a history of narrow-angle glaucoma.
- Patients who have had previous surgery for PD (including but not limited to deep brain stimulation [DBS] or cell transplantation).
- Patients with a history of psychotic symptoms requiring treatment, or suicide ideation or attempt within the prior 12 months.
Sites / Locations
- Acorda Site #7145
- Acorda Site # 7142
- Acorda Site #7139
- Acorda Site #7141
- Acorda Site #7137
- Acorda Site #7135
- Acorda Site #7130
- Acorda Site #7133
- Acorda Site #7134
- Acorda Site #7131
- Acorda Site #7138
- Acorda Site #7140
- Acorda Site #7150
- Acorda Site #7148
- Acorda Site #7004
- Acorda Site #7002
- Acorda Site #7003
- Acorda Site #7011
- Acorda Site #7012
- Acorda Site #7013
- Acorda Site #7024
- Acorda Site #7025
- Acorda Site #7021
- Acorda Site #7022
- Acorda Site #7023
- Acorda Site #7036
- Acorda Site #7037
- Acorda Site #7034
- Acorda Site #7031
- Acorda Site #7033
- Acorda Site #7032
- Acorda Site #7035
- Acorda Site #7041
- Acorda Site #7043
- Acorda Site #7049
- Acorda Site #7050
- Acorda Site #7048
- Acorda Site #7047
- Acorda Site #7046
- Acorda Site #7042
- Acorda Site #7044
- Acorda Site #7053
- Acorda Site #7051
- Acorda Site #7062
- Acorda Site #7064
- Acorda Site #7061
- Acorda Site #7063
- Acorda Site #7045
- Acorda Site #7085
- Acorda Site #7084
- Acorda Site #7083
- Acorda Site #7086
- Acorda Site #7087
- Acorda Site #7082
- Acorda Site #7081
- Acorda Site #7088
- Acorda Site #7094
- Acorda Site #7092
- Acorda Site #7093
- Acorda Site #7091
- Acorda Site #7095
- Acorda Site #7101
- Acorda Site #7102
- Acorda Site #7103
- Acorda Site #7112
- Acorda Site #7116
- Acorda Site #7111
- Acorda Site #7120
- Acorda Site #7119
- Acorda Site #7113
- Acorda Site #7118
- Acorda Site #7114
- Acorda Site #7115
- Acorda Site #7123
- Acorda Site #7121
- Acorda Site #7122
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
CVT-301
Observational Cohort
Arm Description
Capsules of Levodopa Inhalational Powder (LIP) used up to 5 times per day for OFF episodes, for up to 54 weeks duration.
Standard of care. Patients in both the CVT-301 treatment group and the observational cohort will be managed with their standard PD treatment throughout the study.
Outcomes
Primary Outcome Measures
Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second [FEV1]
To characterize the pulmonary safety, as assessed by spirometry (forced expiratory volume in 1 second [FEV1], over a 12 month period.
Pulmonary Safety Assessed by Forced Vital Capacity [FVC].
To characterize the pulmonary safety, as assessed by spirometry (forced vital capacity).
Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second / Forced Vital Capacity Ratio.
To characterize the pulmonary safety, as assessed by spirometry (forced expiratory volume in 1 second / forced vital capacity ratio).
Secondary Outcome Measures
Diffusion Capacity of the Lungs for Carbon Monoxide (DLco).
To describe the effects of CVT-301 on diffusion capacity of the lungs for carbon monoxide (DLco) over a 12-month period.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02352363
Brief Title
Randomized Safety Study of CVT-301 Compared to an Observational Control Group
Official Title
A Phase 3, Randomized Study Investigating the Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson's Disease (PD) Patients With Motor Response Fluctuations (OFF Phenomena) Compared to an Observational Cohort Control
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acorda Therapeutics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is a 12-month, open-label, randomized, multicenter study which will evaluate the safety and efficacy of CVT-301 for the treatment of up to 5 OFF episodes per day in Parkinson's Disease (PD) patients experiencing motor fluctuations (OFF episodes) and will include a concurrent observational cohort of PD patients managed using the usual standards of care.
Detailed Description
A randomized, double-blind, placebo-controlled, Phase 2b study in patients with PD (CVT-301-003) demonstrated clinically important, and statistically significant CVT-301-associated improvements in motor function at doses of 35 and 50 mg LD FPD, compared with placebo, as measured by the Unified Parkinson's Disease Rating Scale (UPDRS) motor assessment (Part 3); furthermore, CVT-301 was generally safe and well tolerated. A Phase 3, randomized, placebo-controlled study designed to assess the efficacy and safety of 35 mg and 50 mg FPD as an adjunct to a CD/LD regimen in the treatment of OFF symptoms over 12 weeks (CVT-301-004) was conducted in parallel with this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Parkinson's Disease
Keywords
Parkinson's Disease, Motor fluctuations, levodopa, inhaled drugs, OFF episodes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
408 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CVT-301
Arm Type
Experimental
Arm Description
Capsules of Levodopa Inhalational Powder (LIP) used up to 5 times per day for OFF episodes, for up to 54 weeks duration.
Arm Title
Observational Cohort
Arm Type
Other
Arm Description
Standard of care. Patients in both the CVT-301 treatment group and the observational cohort will be managed with their standard PD treatment throughout the study.
Intervention Type
Drug
Intervention Name(s)
CVT-301
Other Intervention Name(s)
Inhaled levodopa
Intervention Type
Other
Intervention Name(s)
Observational cohort
Primary Outcome Measure Information:
Title
Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second [FEV1]
Description
To characterize the pulmonary safety, as assessed by spirometry (forced expiratory volume in 1 second [FEV1], over a 12 month period.
Time Frame
Month 12 reported
Title
Pulmonary Safety Assessed by Forced Vital Capacity [FVC].
Description
To characterize the pulmonary safety, as assessed by spirometry (forced vital capacity).
Time Frame
Month 12 reported
Title
Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second / Forced Vital Capacity Ratio.
Description
To characterize the pulmonary safety, as assessed by spirometry (forced expiratory volume in 1 second / forced vital capacity ratio).
Time Frame
Month 12 reported
Secondary Outcome Measure Information:
Title
Diffusion Capacity of the Lungs for Carbon Monoxide (DLco).
Description
To describe the effects of CVT-301 on diffusion capacity of the lungs for carbon monoxide (DLco) over a 12-month period.
Time Frame
Month 12 reported
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has signed and dated an Internal Review Board/Independent Ethics Committee (IRB/IEC)-approved informed consent form before any protocol-specific screening procedures are performed.
Women of child-bearing potential must use protocol-defined contraceptive measures and must have a negative serum human chorionic gonadotropin (hCG) test at screening. These patients must be willing to remain on their current form of contraception for the duration of the study.
Patients who have idiopathic PD (i.e., not induced by drugs or other diseases) as defined by fulfilling Steps 1 and 2 of the United Kingdom (UK) Brain Bank criteria, diagnosed after the age of 30 years.
Patients who are classified as Stage 1 to 3 (in the ON state) on the modified Hoehn and Yahr scale for staging of PD severity.
Patients who have experienced motor fluctuations for a minimum of 2 hours of average daily OFF time per waking day (excluding early morning OFF time) by self-report and confirmed by the PD Diary (on 3 consecutive days) during the screening period.
Exclusion Criteria:
Patients who have dyskinesia of a severity that would significantly interfere with their ability to participate or perform study procedures.
Pregnant or lactating females or females wishing to become pregnant.
Patients who have any known contraindication to the use of levodopa (LD), including a history of malignant melanoma or a history of narrow-angle glaucoma.
Patients who have had previous surgery for PD (including but not limited to deep brain stimulation [DBS] or cell transplantation).
Patients with a history of psychotic symptoms requiring treatment, or suicide ideation or attempt within the prior 12 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Oh, MD
Organizational Affiliation
Acorda Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Acorda Site #7145
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Acorda Site # 7142
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Acorda Site #7139
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Acorda Site #7141
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94085
Country
United States
Facility Name
Acorda Site #7137
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Acorda Site #7135
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33713
Country
United States
Facility Name
Acorda Site #7130
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Acorda Site #7133
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Acorda Site #7134
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Acorda Site #7131
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Acorda Site #7138
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96734
Country
United States
Facility Name
Acorda Site #7140
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Acorda Site #7150
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70810
Country
United States
Facility Name
Acorda Site #7148
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Acorda Site #7004
City
Innsbruck
ZIP/Postal Code
64239
Country
Austria
Facility Name
Acorda Site #7002
City
Linz
ZIP/Postal Code
04021
Country
Austria
Facility Name
Acorda Site #7003
City
Vienna
ZIP/Postal Code
01220
Country
Austria
Facility Name
Acorda Site #7011
City
Brussels
ZIP/Postal Code
01200
Country
Belgium
Facility Name
Acorda Site #7012
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
Acorda Site #7013
City
Ghent
ZIP/Postal Code
09000
Country
Belgium
Facility Name
Acorda Site #7024
City
Chocen
ZIP/Postal Code
12163
Country
Czechia
Facility Name
Acorda Site #7025
City
Ostrava
ZIP/Postal Code
70852
Country
Czechia
Facility Name
Acorda Site #7021
City
Pardubice
ZIP/Postal Code
27574
Country
Czechia
Facility Name
Acorda Site #7022
City
Prague 10
ZIP/Postal Code
10000
Country
Czechia
Facility Name
Acorda Site #7023
City
Rychnov nad Kneznou
ZIP/Postal Code
516 01
Country
Czechia
Facility Name
Acorda Site #7036
City
Amiens
ZIP/Postal Code
80054Cedex1
Country
France
Facility Name
Acorda Site #7037
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Acorda Site #7034
City
Marseille Cedex 05
ZIP/Postal Code
13385
Country
France
Facility Name
Acorda Site #7031
City
MONTPELLIER Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Acorda Site #7033
City
Nimes Cedex
ZIP/Postal Code
30029
Country
France
Facility Name
Acorda Site #7032
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Acorda Site #7035
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Acorda Site #7041
City
Achim
ZIP/Postal Code
28832
Country
Germany
Facility Name
Acorda Site #7043
City
Beelitz-Heilstätten
ZIP/Postal Code
14547
Country
Germany
Facility Name
Acorda Site #7049
City
Berlin
ZIP/Postal Code
12163
Country
Germany
Facility Name
Acorda Site #7050
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Acorda Site #7048
City
Bremerhaven
ZIP/Postal Code
27574
Country
Germany
Facility Name
Acorda Site #7047
City
Cologne
ZIP/Postal Code
50937
Country
Germany
Facility Name
Acorda Site #7046
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Acorda Site #7042
City
Munich
ZIP/Postal Code
80804
Country
Germany
Facility Name
Acorda Site #7044
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Acorda Site #7053
City
Budapest
ZIP/Postal Code
01033
Country
Hungary
Facility Name
Acorda Site #7051
City
Budapest
ZIP/Postal Code
01135
Country
Hungary
Facility Name
Acorda Site #7062
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Acorda Site #7064
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Acorda Site #7061
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Acorda Site #7063
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Acorda Site #7045
City
Den Haag
ZIP/Postal Code
83527
Country
Netherlands
Facility Name
Acorda Site #7085
City
Gdansk
ZIP/Postal Code
80-462
Country
Poland
Facility Name
Acorda Site #7084
City
Katowice
ZIP/Postal Code
40-588
Country
Poland
Facility Name
Acorda Site #7083
City
Kracow
ZIP/Postal Code
08026
Country
Poland
Facility Name
Acorda Site #7086
City
Kraków
ZIP/Postal Code
30-349
Country
Poland
Facility Name
Acorda Site #7087
City
Kraków
ZIP/Postal Code
31-505
Country
Poland
Facility Name
Acorda Site #7082
City
Lodz
ZIP/Postal Code
90-130
Country
Poland
Facility Name
Acorda Site #7081
City
Warsaw
ZIP/Postal Code
01-868
Country
Poland
Facility Name
Acorda Site #7088
City
Warsaw
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Acorda Site #7094
City
Brasov
ZIP/Postal Code
500283
Country
Romania
Facility Name
Acorda Site #7092
City
Brasov
ZIP/Postal Code
500365
Country
Romania
Facility Name
Acorda Site #7093
City
Bucharest
ZIP/Postal Code
12051
Country
Romania
Facility Name
Acorda Site #7091
City
Constanta
ZIP/Postal Code
900591
Country
Romania
Facility Name
Acorda Site #7095
City
Targu Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
Acorda Site #7101
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Acorda Site #7102
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Acorda Site #7103
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Acorda Site #7112
City
Sant Cugat
State/Province
Barcelona
ZIP/Postal Code
08195
Country
Spain
Facility Name
Acorda Site #7116
City
Barcelona
ZIP/Postal Code
08026
Country
Spain
Facility Name
Acorda Site #7111
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Acorda Site #7120
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Acorda Site #7119
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Acorda Site #7113
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Facility Name
Acorda Site #7118
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Acorda Site #7114
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Acorda Site #7115
City
San Sebastian
ZIP/Postal Code
20009
Country
Spain
Facility Name
Acorda Site #7123
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Acorda Site #7121
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Acorda Site #7122
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
33866196
Citation
Kaminsky DA, Grosset DG, Kegler-Ebo DM, Cangiamilla S, Klingler M, Zhao P, Oh C. Natural history of lung function over one year in patients with Parkinson's disease. Respir Med. 2021 Jun;182:106396. doi: 10.1016/j.rmed.2021.106396. Epub 2021 Apr 16.
Results Reference
derived
Links:
URL
http://cvt301.acordatrials.com/
Description
Click here for more information about this study:CVT-301-005
Learn more about this trial
Randomized Safety Study of CVT-301 Compared to an Observational Control Group
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